A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

Trial Information

A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

The combination of AZT and chemotherapy may be effective in treating the tumor as well as
preventing the life-threatening infections when used for patients with AIDS and Kaposi's
sarcoma. The MTD of combined chemotherapy is being determined so that the information will
be available for future studies, when the relative effectiveness of the two doses of AZT has
been learned.

AMENDED: AZT by mouth. If the treatment is well tolerated, subsequent groups of patients are
started on increasing doses of doxorubicin combined with the same dose of bleomycin and
vincristine. After determination of the MTD of chemotherapy in combination with AZT, the 2nd
phase begins in which AZT is given and the first group of patients is given bleomycin and
vincristine only. If this combination is well tolerated, then the subsequent groups are
started on increasing doses of doxorubicin with the same dose of bleomycin, vincristine and
AZT. The MTD of chemotherapy in combination with AZT is then determined. Patients achieving
maximum response to the tumor are maintained on AZT alone. This is an outpatient study, and
patients are seen every 2 weeks for evaluation, with a physical examination every month.
Original design: The combination of chemotherapy and AZT is given to groups of four patients
each, the first group beginning with bleomycin and vincristine, without the addition of
doxorubicin. The chemotherapy is given intravenously every 2 weeks. This is combined first
with AZT by mouth.

- Any drugs causing anemia, neutropenia, or significant risk of nephrotoxicity.
Patients with a history of other systemic malignancies or lymphomas, except carcinoma
in situ of the cervix or localized squamous or basal cell carcinoma of the skin, will
be excluded from the study.

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